NCT04258514

Brief Summary

The primary purpose of the study is to determine if the use of Virtual Reality (VR) goggles reduces the degree of anxiety patients experience during vasectomy procedures. The eligibility criteria include a.) appropriate age (19-100 years); b.) undergoing elective vasectomy procedure for purpose of desired sterility; c.) acceptance of wearing goggles; d) able to provide informed consent.There will be two groups, Group A will wear VR goggles and Group B will not. Evaluations will be done by survey to include questions regarding the level of anxiety experienced during the procedure, along with satisfaction scores of the experience.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
1.2 years until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2021

Completed
Last Updated

August 15, 2023

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

January 31, 2020

Last Update Submit

August 12, 2023

Conditions

VasectomyVirtual Reality

Outcome Measures

Primary Outcomes (3)

  • Procedure anxiety

    Procedure anxiety measured by Beck Anxiety Inventory

    during vasectomy Procedure

  • Procedure anxiety

    Procedure anxiety measured by Beck Anxiety Inventory

    10 minutes prior to procedure start

  • Procedure anxiety

    Procedure anxiety measured by Beck Anxiety Inventory

    10 minutes after procedure ends

Study Arms (2)

Virtual Reality Vasectomy

EXPERIMENTAL

This group of men will undergo vasectomy while wearing VR goggles.

Procedure: Virtual Reality during vasectomy

Standard Vasectomy

EXPERIMENTAL

This group of men will undergo a standard vasectomy without using VR goggles.

Procedure: Standard Vasectomy

Interventions

Virtual Reality during vasectomyPROCEDURE

Virtual Reality

Virtual Reality Vasectomy
Standard VasectomyPROCEDURE

No Virtual Reality

Standard Vasectomy

Eligibility Criteria

Age19 Years - 100 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsonly men have vasectomy.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Appropriate age range (19-100 years)
  • Undergoing elective vasectomy procedure in the urology clinic
  • Willing to sign consent to participate in the study

You may not qualify if:

  • Visually impaired (blind)
  • years of age or younger
  • Subjects under the influence of medications will not be approached regarding study participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Christopher M Deibert, MD, MPH

    University of Nebraska

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
cannot make due to either wearing or not wearing the VR device
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2020

First Posted

February 6, 2020

Study Start

April 1, 2021

Primary Completion

June 23, 2021

Study Completion

June 23, 2021

Last Updated

August 15, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share